Lexicon Pharmaceuticals Inc.'s Xermelo, a carcinoid syndrome diarrhea treatment created in collaboration with Ipsen, has been given a positive opinion for Marketing Authorization Application (MAA) by the Committee for Medicinal Products for Human Use (CHMP), the committee of the European Medicines Agency (EMA) responsible for human medicines.
The European Commission will now make a final decision on whether to approve the MAA for the drug, and it will use the CHMP’s recommendation when making its decision. A decision should come by the third quarter of 2017.
If approved, Xermelo will be authorized for marketing in all 28 countries of the European Union.
"Xermelo was approved in the U.S. in February, and the CHMP’s positive opinion marks another important step forward in providing the first oral treatment option for adults affected by this rare disease in Europe,” Dr. Pablo Lapuerta, Lexicon's executive vice president and chief medical officer, said in a statement. “We thank the carcinoid syndrome community for their continued support, including the adults, families and caregivers who gave their time to participate in the clinical trials of telotristat ethyl with the goal of making this treatment a reality for patients."